Welch Allyn® ELI 230® Resting Electrocardiograph - HSA Registration DE0503916
Access comprehensive regulatory information for Welch Allyn® ELI 230® Resting Electrocardiograph in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503916 and owned by Welch Allyn Inc.. The device was registered on December 09, 2019.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
• Device is indicated for use to acquire, analyze, display, and print electrocardiograms. • Device is indicated for use for patients of any age • Device is indicated for use to provide interpretation of the data for consideration by a physician. It is not intended as a sole means of diagnosis. • The interpretations of ECG offered by the device are only significant when used in conjunction with physician over read as well as consideration of all other relevant patient data. • The device is not intended to be used as a vital signs physiological monitor. • The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. • The device is not designed for use in highly invasive environments, such as an operating theatre.